07-253. Prospective Grant of Exclusive License: Devices for Countercurrent Chromatography

AGENCY:

National Institutes of Health, Public Health Service, HHS.

ACTION:

Notice.

SUMMARY:

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in: HHS Ref. No. E-274-1998 “Chromatographic Separation Apparatus and Method,” U.S. Patent No. 6,379,973; HHS Ref. No. E-044-1993 “Variable-Position Cross-Axis Synchronous Coil Plant Centrifuge for Countercurrent Chromatography;” U.S. Patent 5,380,429; HHS Ref. No. E-148-2001 “Method and Apparatus for Countercurrent Chromatography;” U.S. Patent Application No. 10/509,697 filed April 5, 2002; to CC Biotech LLC, a company incorporated under the laws of the State of Maryland having its headquarters in Rockville, Maryland. The United States of America is the assignee of the rights of the above inventions. The contemplated exclusive license may be granted in a field of use limited to instrumentation for countercurrent chromatographic purification of proteins and peptides.

DATES:

Only written comments and/or applications for a license received by the NIH Office of Technology Transfer on or before March 23, 2007 will be considered.

ADDRESSES:

Requests for a copy of the patent application, inquiries, comments and other materials relating to the contemplated license should be directed to: Michael A. Shmilovich, Esq., Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: [phone]; Facsimile: [phone]; E-mail: [e-mail]. A signed confidentiality nondisclosure agreement will be required to receive copies of any patent applications that have not been published by the United States Patent and Trademark Office or the World Intellectual Property Organization.

SUPPLEMENTARY INFORMATION:

The patents and patent applications intended for licensure disclose or cover the following:

E-274-1998, “Chromatographic Separation Apparatus and Method,” U.S. Patent No. 6,379,973

This invention pertains to an apparatus and method for separating bio-molecules using a salt (e.g., ammonium sulfate) gradient applied in a spiral flow channel divided by a dialysis membrane. The channels are compartmentalized into upper and lower rotary discs spinning anti-clockwise to each other. Sample is introduced in a buffered solution into the lower channel flows in one direction while the salt flows in the other. The concentration of salt permeates the membrane and precipitates the large molecules on the other side. For example, proteins or polymers are precipitates sequentially in the channel and centrifugal forces the precipitate to the outer rim as it moves along the liquid stream.

E-044-1993, “Variable-Position Cross-Axis Synchronous Coil Planet Centrifuge for Countercurrent Chromatography,” U.S. Patent No. 6,379,973

This device is a cross-axis synchronous flow-through coil planet centrifuge which provides changeability in the position of the coils relative to the axis of rotation of the centrifuge. The advantage of this feature is to allow adjustment of the centrifugal force operating on the coils to accommodate different types of separations. The coils are arranged in columns which are mounted to column holders that in turn can be engaged to the rotary frame of the centrifuge in position in which the column holders intersect and do not intersect the rotary frame axis. This arrangement allows for larger coils which can hold between 200 ml and 800 ml of sample.

E-148-2001, “Method and Apparatus for Countercurrent Chromatography,” U.S. Patent Application No. 10/509,697 (WIPO publication 03/087807)

This device and method is an improvement of the countercurrent chromatography devices described above. This patent pending device is a new spiral design capable of holding heavier solvent systems suitable for peptides and proteins (e.g., for natural products).

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within sixty (60) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

Dated: January 12, 2007.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.